Results from Pivotal Phase 3 ATTACK Trial of Investigational Sulbactam-Durlobactam for Treatment of Serious Infections Caused by Acinetobacter Published

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, focused on delivering innovative therapies in critical care and infectious disease, today announced that The Lancet Infectious Diseases published detailed results from the pivotal Phase 3 ATTACK trial of sulbactam-durlobactam, the first pathogen-targeted therapy being studied for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). The study – Efficacy and Safety of Sulbactam-Durlobactam vs. Colistin for the Treatment of Patients with Serious Infections due to Acinetobacter Baumannii-Calcoaceticus Complex: a multicentre, randomised, active-controlled, Phase 3, non-inferiority clinical trial (ATTACK) – was first published online on May 11.

The Phase 3 trial evaluated the safety and efficacy of sulbactam-durlobactam versus colistin in patients with infections caused by Acinetobacter. In the trial, sulbactam-durlobactam demonstrated statistical non-inferiority versus colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections and a significant difference in clinical cure rates. Sulbactam-durlobactam also exhibited a favorable safety profile with a statistically significant lower incidence of nephrotoxicity as measured by modified Risk–Injury–Failure–Loss and End-stage kidney disease (RIFLE) criteria.

“Serious bacterial infections caused by Acinetobacter baumannii-calcoaceticus complex often result in death, as the pathogen is increasingly resistant to carbapenems and other existing agents,” said Keith Kaye, MD, MPH, Chief, Division of Allergy, Immunology and Infectious Diseases at Rutgers Robert Wood Johnson Medical School. “The safety and efficacy demonstrated during the Phase 3 ATTACK trial by sulbactam-durlobactam, which was designed specifically for treating serious infections caused by Acinetobacter, are very promising, and provide hope that we’ll have a novel, desperately needed, effective treatment option against this lethal pathogen.”

Infections caused by drug-resistant Acinetobacter are serious and life-threatening conditions associated with high morbidity and mortality and long, expensive hospital stays. Acinetobacter is resistant to penicillins and has also acquired resistance genes for almost all antibiotics used to treat Gram-negative bacteria, including fluoroquinolones, aminoglycosides, cephalosporins, and carbapenems.